Table 2.

Recommendations for vulnerable populations in PCTs

• When designing a PCT, inclusion of participants who may be members of a vulnerable category should be considered, and how the ethical and regulatory requirements will be assessed and managed should be addressed in the study.

• There should not be a differential burden of research nor differential access to research for one group relative to any other. Therefore, being part of a vulnerable population should not be an exclusion criterion.

• In general, PCTs not targeting vulnerable subjects should not seek to identify vulnerable subjects within the study for the sole purpose to exclude them. This could stigmatize the vulnerable group and risk violating confidentiality and loss of research data for that group.

• PCTs where a vulnerable population is the focus of the study rather than a member of a larger group, should address the protections for that group. PCTs where vulnerable subjects are included as part of a larger population should be evaluated based on the level of risk and the characteristics being studied.

• Revisit the regulations to consider the characteristics of the participants and the incremental risk of the research design to determine the need for added protection for vulnerable populations.

PCT, pragmatic clinical trial.